Systems and methods for hair loss management

ABSTRACT

Comprehensive systems and methods for managing hair loss are provided which enable an individual experiencing hair loss, and/or the person consulting him or her, to manage it and to determine and efficiently plan any appropriate treatment options. Management of hair loss may comprise quantifying hair loss, determining what hair growth stimulation product or treatment to adopt and the best timing for such products and/or treatments, and allowing to track and manage any progress of the selected hair growth stimulation product or treatment.

TECHNICAL FIELD

This disclosure relates generally to management of cosmetic anddermatological procedures. In particular, this disclosure relates tohair loss management systems, devices and methods of their use,including hair transplantation planning systems or other systems,devices and apparatus for planning hair loss treatment options andmethods of their use.

BACKGROUND

Hair loss is a common problem experienced by many, both men and women,with the loss of hair being temporary or a gradual process leading to apermanent loss. There are numerous reasons for hair loss, including forexample a deficiency/excess in vitamins, minerals, or other elementsrequired for a healthy diet, hormonal changes, a trauma (such as thatresulting from a surgical procedure, an accident, excessive weight loss,or a stressful event such as pregnancy), stress, a medical conditionsuch as diabetes, male/female patterned baldness, or age. In otherinstances hair loss may result from the intake of certain medications,be a side-effect of certain drugs, or result from the excessive use ofhair treatments.

The solution to the problem of hair loss, whether the hair loss istemporary, progressive or permanent, varies from patient to patient. Anindividual's decision on how to cope with their hair loss is based on acombination of factors, typically including whether the individual ismale or female, their age, ethnicity, genetic disposition, health anddiet considerations, personal goals or desires, and/or the stage oftheir hair loss. In addition, the availability and associated cost ofoptions available, the inconvenience caused in terms of preparationtime, procedure time, recovery time, pain and/or discomfort, peertolerance or acceptance, input provided from friends, family andconsultants, and emotion also play a role.

Depending upon the reason for hair loss, the solutions to remedy thetemporary or permanent problem are as numerous as the reasons for hairloss. Solutions including, but not limited to, the use of products thatcan be applied topically to promote hair growth and/or reduce hair loss,special shampoos and other applications, wigs, laser treatments orsurgical solutions such as hair transplantations.

Hair transplantation procedures are well-known, and typically involve(e.g., in a patient having male pattern baldness) harvesting donor hairgrafts from the side and back fringe areas (“donor areas”) of thepatient's scalp, and implanting the harvested follicular units in a baldarea (“recipient area”). Commonly assigned U.S. Pat. No. 6,585,746discloses a hair transplantation system utilizing a robotic system,including a robotic arm and a hair follicle introducer associated withthe robotic arm. An imaging system is used to produce athree-dimensional image of the patient's scalp, which is used to planthe locations to receive hair grafts. Hair transplantation proceduresthat are carried out using automated (including robotic) systems orcomputer-controlled systems have been described, for example, in U.S.Pat. No. 7,962,192, commonly owned by the assignee of the presentdisclosure, which is incorporated herein by reference. After the roboticsystem has been initiated and calibrated, image data of the body surfaceis acquired and processed by the system computer to identify objects, inparticular follicular units in a donor area, for example, on a humanscalp. From images of this area of interest, image segmentation andscreening software identifies and selects particular follicular units ofinterest for harvesting from the scalp.

Commonly assigned U.S. Pat. Nos. 7,806,121 and 8,104,480 (hereinaftercollectively, “Bodduluri”) illustrate systems and methods for planningtransplantation of follicular units into a body surface of the patient.The entire disclosures of both above-identified U.S. patents areincorporated by reference.

SUMMARY

A variety of systems and methods for planning various cosmetic anddermatological procedures, including hair transplantation, are providedin the present disclosure. These procedures may be performed on thescalp, face and other skin and body surfaces.

According to one aspect of the present disclosure, a method fordetermining and managing hair loss (or hair health) on a body surface isprovided. In various embodiments, the method comprises calculating ametric of hair loss or hair health. Such calculation of the metric maybe accomplished in real time, providing accurate and concurrent data toboth patients and medical practitioners. For example, the method maycomprise: identifying one or more site locations on the body surfacewithin a predetermined region; determining a value associated with eachof the one or more site locations (each value may be determined, forexample, by how many hair follicles (or in some embodiments hair grafts)are located within a boundary or certain area relative to the sitelocation); assigning a representation to one or more of the determinedvalues; populating the predetermined region with one or morerepresentations of the determined values; determining proportions ofeach type of representation in the predefined region; and calculating ametric of hair loss or hair health based at least in part on thedetermined proportions.

In some embodiments, it may be determined if the hair or hair graftcomprises one or more terminal hair based on, for example, one or moreof a caliber, color, length or specifics of a particular patient. Thesize of the site location may vary depending on a particularimplementation, in some embodiments it may be, for example, between 1-2cm², and preferably 1 cm². A user may select an association between thedetermined values and the assigned representation via a remote inputdevice, stylus, pen, finger(s), by drop-down menus, or touch screencommands and gestures.

In other embodiments the determined value comprises a first value ifsubstantially no hair is located within the boundary of the sitelocation, and a second value if one or more hairs are located within theboundary of the site location. In other embodiments the determined valuefurther comprises a third value if two or more hairs are located withinthe boundary of the site location.

In various embodiments a visual representation of the body surface ispopulated with representations of the determined values for each of theplurality of site locations, showing an extent of hair loss. In otherembodiments the value associated with the procedure site location isdetermined at a first and a second instance in time, and metric furthercomprises determining a difference in an area covered by each of the oneor more representations between the first and the second instance intime. In some embodiments the first instance of time is prior to a hairtreatment process having been performed, and the second instance in timeis after a hair treatment process has been performed. In otherembodiments the hair treatment process comprises a hair transplantationprocedure, or an application of a hair treatment product, administeringone or more medications or a therapy. According to a further aspect ofthe current disclosure a system is provided for determining and managinghair loss or hair health on a body surface, including, for example, asystem for calculating a metrics of hair loss. The system may comprise:at least one non-transitory storage medium storing instructions, and oneor more modules for executing operations on image data, the one or moremodules comprising instructions for: identifying one or more sitelocations on the body surface within a predefined region; determining avalue associated with each of the one or more site locations, each valuedetermined by how many hairs are located within a boundary of the sitelocation; assigning a representation to one or more of the determinedvalues; populating the predefined region with one or morerepresentations of the determined values; determining proportions ofeach type of representation in the predefined region; and calculating ametric of hair loss or hair health based at least in part on thedetermined proportions. The software/program for executing instructionsfor determining hair metric (or any other methodology of the presentdisclosure) may be used in conjunction with a mobile device (e.g., smartphone), tablet, iPad, laptop, personal computer or other processingunit.

In a yet further aspect of the current disclosure a computer-implementedmethod for determining and managing hair loss on a body surface isprovided, the method comprising: identifying one or more regions ofinterest (for example, potential recipient area or potential donor area)on a body surface; automatically determining a proportion of terminaland/or non-terminal hair within the one or more regions of interest;automatically analyzing proportions of classes of follicular unitswithin the one or more regions of interest; and predicting a rate ofadvancement of hair loss based, at least in part, on the proportion ofterminal and/or non-terminal hair and proportions of classes offollicular units within one or more regions of interest. In someimplementations, the one or more regions of interest may be a potentialdonor area such that the methodology would allow to predict how muchhair may be available in the future in such donor area based at least inpart on the rate of advancement of the hair loss. In otherimplementations the method may comprise ranking of the one or moreregions of interest based on the proportion of classes of follicularunits.

In some embodiments, the method may further comprise assigning a hairloss value to the body surface and reassigning the hair loss value as ofa future date based on the predicted rate of advancement of hair loss.In other embodiments, the method may comprise determining a number offollicular units in each class taking into consideration existence ofterminal and non-terminal hair, wherein each class is based on a numberof hair follicles in a follicular unit.

According to a still further aspect of the current disclosure, a systemis provided for determining and managing hair loss on a body surface,the system comprising: at least one non-transitory storage mediumstoring instructions, and one or more modules for executing operationson image data, the one or more modules comprising instructions for:identifying one or more regions of interest on a body surface;automatically determining a proportion of terminal and/or non-terminalhair within the one or more regions of interest; automatically analyzingproportions of classes of follicular units within the one or moreregions of interest; and predicting a rate of advancement of hair lossbased, at least in part, on the proportion of terminal and/ornon-terminal hair and proportions of classes of follicular units withinthe one or more regions of interest.

According to an additional aspect of the disclosure a computerimplemented method is provided for determining and managing hair loss ona body surface, the method comprising: identifying regions on a bodysurface, the regions comprising a potential donor area and a potentialrecipient area; automatically determining proportion of terminal and/ornon-terminal hair within the potential donor area and the potentialrecipient area; automatically analyzing proportions of classes offollicular units within the potential donor area; automaticallyanalyzing proportions of classes of follicular units within thepotential recipient area; and proposing one or more actions for managinghair loss based, at least in part, on the determined proportion ofterminal and/or non-terminal hair, the proportions of classes offollicular units within the potential recipient area, and theproportions of classes of follicular units within the potential donorarea. In some implementations, the method may comprise determining orproposing potential timing for performing a procedure or a treatment forhair loss. In some embodiments, the step of proposing one or moreactions may be performed automatically by the automated system, in otherembodiments a physician may choose one of several available options, forexample, from a user interface, or use the results of the automateddetermination to propose an action or treatment option(s).

In some embodiments, the method may further comprise assigning a hairloss value to the body surface based on the identified regions. In otherembodiments automatically analyzing proportions of classes of follicularunits may further comprise determining a density in the potential donorarea and automatically proposing that a hair transplantation procedurenot be considered at present if the hair density is less than 40 hairsper 1 cm². In further embodiments, the method may comprise determining adensity in the potential recipient area and automatically proposing thata hair transplantation be considered at present or during certainproposed time frame if the hair density is less than a predeterminednumber of hair follicles or follicular units per unit area. In certainembodiments the method may comprise determining a number of follicularunits in each class taking into consideration existence of terminal andnon-terminal hair follicles, wherein each class is based on a number ofhair follicles in a follicular unit.

In a still further aspect of the current disclosure, a system fordetermining and managing hair loss on a body surface is provided, thesystem comprising: at least one non-transitory storage medium storinginstructions, and one or more modules for executing operations on imagedata, the one or more modules comprising instructions for: identifyingregions on a body surface, the regions comprising a potential donor areaand a potential recipient area; automatically determining proportion ofterminal and/or non-terminal hair follicles within the potential donorarea and the potential recipient area; automatically analyzingproportions of classes of follicular units within the potential donorarea; automatically analyzing proportions of classes of follicular unitswithin the potential recipient area; and proposing one or more actionsfor managing hair loss based, at least in part, on the determinedproportion of terminal and/or non-terminal hair follicles, theproportions of classes of follicular units within the potentialrecipient area, and the proportions of classes of follicular unitswithin the potential donor area.

According to yet further aspects of the present disclosure, devices,systems and methods are provided that allow making treatment optiondecisions based on simulation and analysis of the development of thehair growth or hair loss of a subject over a period of time.

According to a further aspect of the present disclosure a methodologyfor computer implemented realistic simulation of hair loss or hair gain(e.g., resulting from the treatment, such as hair transplantation orother hair restoration) is provided. For example, in reference tosimulating hair gain, the method comprises displaying individual hairfollicles or follicular units in an image of a region of interestexperiencing hair loss; simulating or allowing the user to simulate anappearance of the region of interest with an increase in density ofhair; and automatically adjusting the simulated appearance of theincreased density to reflect an achievable density that accounts for oneor more calculated constraints. In some embodiments an automatedadjustment takes into account one or more of the following: an availablenumber of hair grafts in a donor area, associated classification ofavailable donor hair grafts, one or more of a color, length or caliberor hair, size of the area of interest, average distance between hairfollicles or follicular units, size of a tool, how close hair may beimplanted to existing or previously implanted hair, geometric patternsformed by the hair locations, and system limitations. In someembodiments, the methodology may comprise simulating the increaseddensity by duplicating one or more of the displayed individual hairfollicles or follicular units in the image of the region of interest,simulating hair gain. In reference to simulating hair loss, in someembodiments the methodology may comprise substantially masking one ormore of the displayed individual hair follicles or follicular units inthe image of the region of interest.

A method for using analysis of hair growth phase to plan hairtransplantation is also provided. The method comprising: identifying oneor more hair follicles within a predefined region on the body surface;determining a type of hair growth phase for the one or more hairfollicles; determining a proportion of hair in an anagen hair growthphase; assigning a representation to and populating the predefinedregion with only those representations corresponding to hair in theanagen hair growth phase; and planning a hair transplantation procedurebased, at least in part, on the determined proportion of the anagen hairand/or on a distribution of the populated representation.

According to yet another aspect, a method of determining which hairs toharvest from a donor area is provided. The method comprising: detectinghairs in an image of a donor area; determining which of the detectedhairs are in an anagen growth phase; and determining which hairs toharvest from the donor area based on the determination of hairs in theanagen growth phase. In some embodiments the method further comprisesharvesting fewer than all of the hairs identified as being in the anagengrowth phase, such that some anagen growth phase hair remains in thedonor area. In certain embodiments the method may further compriseautomatically harvesting some or all of the determined hair, forexample, by means of a robotic arm coupled to a hair harvesting tool.

In addition, a method for determining when to harvest hair from a bodysurface is provided, the method comprising: automatically comparing afirst length of a hair at a first moment in time to a second length ofthe hair at a second moment in time and repeating the comparison for aplurality of hairs in a region of interest; automatically classifyingcompared hairs according to a hair growth phase based on a result of thecomparison of the second length to the first length; automaticallydetermining a proportion or percentage of hairs in the region ofinterest that are in an anagen hair growth phase; and determining whento plan a hair transplantation procedure based, at least in part, on thedetermined proportion or percentage of hairs.

Apparatus, devices and systems (including but not limited to thosecomprising various processors, computing devices, laptops, tablets,iPads, mobile devices, tablets, or microscopic lenses) configured toimplement any of the above methodologies are also provided.

Other and further objects and advantages of various inventions of thepresent disclosure will become apparent from the following detaileddescription when read in view of the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the embodiments described herein will becomeappreciated as the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a flow chart illustrating an example of a general method forcalculating a metric of hair loss.

FIGS. 2a and 2b illustrate examples of the hair loss metric datarepresentations, which may be created according to the methodology ofFIG. 1.

FIGS. 2c-2f illustrate examples of a user interface that may beimplemented with various embodiments of the systems and methods of thepresent disclosure to demonstrate simulated hair loss and/or hair gain,or to display various relevant parameters.

FIG. 3 is a schematic representation of an example of how the valueassociated with the site location may be determined.

FIG. 4 illustrates examples of various regions on a scalp.

FIG. 5 is a flow chart illustrating an example of a general method forpredicting a rate of advancing to the next stage of hair loss.

FIG. 6 is a flow chart illustrating an example of a general method formanaging hair loss, including proposing one or more actions or treatmentoptions and/or the timing of such treatment options.

FIG. 7 is a flow chart illustrating another example of a general methodfor managing hair loss, including determining a phase of the hair growthand the action to take based on the proportion of hair in the determinedhair phase.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

With reference to the above-listed drawings, this section describesparticular embodiments and their detailed construction and operation.The embodiments described herein are set forth by way of illustrationonly and not limitation. Those skilled in the art will recognize inlight of the teachings herein that, for example, other embodiments arepossible, variations can be made to the example embodiments describedherein, and there may be equivalents to the components, parts, or stepsthat make up the described embodiments.

For the sake of clarity and conciseness, certain aspects of componentsor steps of certain embodiments are presented without undue detail wheresuch detail would be apparent to skilled persons in light of theteachings herein and/or where such detail would obfuscate anunderstanding of more pertinent aspects of the embodiments.

Currently there are no comprehensive tools available to enableindividuals to quantify their stage of baldness, make an informedpersonal choice, to assess whether they are making the most suitabledecision (that is the best decision according to scientific evidencebased on the individual's physical and mental status) or if the timingof their solution is being made at the stage of their hair loss processwhich would result in an optimum result. In addition, from thephysician's perspective, there are no comprehensive tools available toassist managing and planning hair loss treatments, as well as theexpectations that patients may have based on their individual hair loss.

Typically, an individual is first aware that he/she has a hair lossproblem when they notice more scalp is visible, as their hair linerecedes, they find more hair dropping out on a daily basis andeventually a bald spot appears. For most, there is a period of denial,or the belief that what they are experiencing is a short term issue, ortemporary hair loss, and the hope that the loss will stop. By the timethat they visit a professional, the progression of hair loss may be suchthat the opportunity to reduce the rate at which they lose hair is lost,more drastic measures are required to regain the appearance they seek,and/or the opportunity to transplant hair from areas with an ample hairsupply has passed due to the overall reduction in hair density, leavingthem with limited options, such as for example, wearing a wig. Forothers, due to genetic disposition, hair loss is expected, but theyoften do not know when it will begin, or the rate at which it willoccur.

The present disclosure provides comprehensive systems and methods formanaging hair loss, enabling the individual experiencing hair lossand/or the physician consulting the patient to manage the hair lossprocess over a period of time, based upon one or more characteristics orparameters of the individual's hair loss, the one or morecharacteristics or parameters typically varying over time. Management ofhair loss may comprise creating a metric of hair loss, identifying hairhealth of a patient, for example, by quantifying the stage of hair loss,managing hair loss to prevent or decrease the rate at which hair isbeing lost, or to restore at least some of the hair that may have beenlost in some area(s). Management may comprise, but is not limited to,the selection of a particular hair enhancement product or treatment, aparticular hair growth supplement, stem cell therapy, shampoo, topicalapplication, or light/photo therapy, administering medication, orrecommending/performing hair transplantation procedure. It also includesmaking suggestions and decisions related to the timing of when toimplement the preceding options, including having a hair transplantationprocedure performed. In addition, the present disclosure allows theindividual and his or her physician to track progress of the selectedhair enhancement product or treatment, allowing for the application ofproduct or treatment to be modified or reconsidered, if required, overthe treatment period.

According to another aspect of the current disclosure a method is alsoprovided by which a physician is able to manage the expectation of apatient as to what can be achieved based on the proportions offollicular units he/she has. The present disclosure provides teachingsfor proposing not only the best solution to a patient's hair loss, butin addition proposing the time at which such solutions should be adoptedor performed. Additionally, providing a comprehensive set of tools toenable one to quantify the level of success achieved by utilizing anyparticular solution.

Metric for Hair Loss

As indicated above, hair loss, or balding, is a complex condition,requiring an understanding of how far one's hair loss has progressed inorder to receive the most suitable treatment. A practitioner typicallydiagnoses the stage of baldness based on appearance, along with a seriesof questions about one's medical history, and the history of hair lossin one's family. When visiting a practitioner, ideally one selects apractitioner of sufficient experience and skill such that they are ableto quantify the stage of hair loss according to an accepted scale ofhair loss, such as the Norwood scale, by comparing one's scalp and hairloss pattern to that of various stages 1-7 of the Norwood scale, orother such scale associated with hair loss. However in most situationsit is difficult for any practitioner to quantify a person's baldness,for example if hair is long or curly, in some instances it may appearthat one has more/less hair than he or she actually does. Depending uponthe practitioner, during the examination a densitometer may also be usedto attain a general idea of the degree of hair loss. The densitometerprovides a measure of hair density in a unit area, such as an area of 10mm² and that area is typically considered representative of the hairdensity throughout one's scalp. However utilizing such a device overone's entire scalp would be an extremely time consuming experience, andwhen all the results were computed, it would be difficult for anypatient to interpret the results, a set of numbers. Consequently,quantifying one's hair loss is not a routine task, and therefore limitsoptions that may otherwise be available to individuals with, forexample, a genetic disposition to balding, to determine at what point intime he/she should consider a hair loss remedy, and perhaps what remedyshould be utilized.

According to an aspect of the present disclosure, a methodology andcorresponding apparatus and systems are provided for determining andmanaging hair loss on a body surface. This aspect provides for adetermination of a metric of baldness to be assigned to a patient. Insome embodiments according to this aspect of the disclosure a visualrepresentation of data may be presented to the patient, physician orother user/operator. Such visual representation (including, for example,a map) assists the operator in quantifying a level of hair loss withrespect to a patient. Such visual representations may be also used toplan future hair treatments, for example identifying areas within whichmedical topical solutions may be applied, areas which may serve aspotential donor areas in a hair transplant, and those which may benefitas potential recipient areas in a future hair transplantation procedure.In some embodiment, such visual representations may also be used totrack the success or otherwise of such medical treatments or hairtransplantation procedures. Further, various representations also may beused in simulating or predicting a possible outcome of a procedure, inmonitoring a procedure in real time, or in reviewing the results of aprocedure (for example, a hair implantation procedure) at a later time.Such representations also may be used to simulate, plan or create hairimplantation sites, as further described in detail in the PatentPublication No. US 2016-0034652 A1 entitled “Systems and Methods forCreating Hair Transplantation Procedure Sites”, the disclosure of whichis incorporated herein by reference.

To aid in the present discussion, reference is made to FIGS. 1, 2 a-f,and 3, which illustrate non-limiting examples of a methodology andtechniques for hair loss quantification and simulation, which may beimplemented on a computer system or one or more machines capable ofexecuting program modules.

FIG. 1 is a flow chart illustrating an example of a general methodology100 employed by one aspect of the present disclosure. FIG. 1 representsa block diagram of methods, apparatus (systems) and computer programproducts according to various embodiments of the present disclosure. Itwill be understood that each block of the flowchart illustrations and/orblock diagrams, and combinations of blocks in the flowchartillustrations and/or block diagrams, can be implemented by computerprogram instructions. The proposed steps may be substantially automated,which means that at least most of the steps could be performedautomatically, for example, by a processor or other computing device. Itdoes not exclude, however, that the user may intervene and participate,for example, by giving an alternative command through a user interface,or override the automated command.

FIGS. 2a and 2b illustrate a representation of a body surface 200, withFIG. 2a representing the body surface 200 at a first instance in time T₁(for example, a patient's first visit to the physician's office) andFIG. 2b representing the same body surface 200 at a second instance intime T₂ (for example, nine months after they have had a hair treatmentapplied, or a hair implantation procedure performed). In an alternative,T₁ may represent an image of a patient's scalp on his first visit to thephysician's office, and T₂ may represent an image of the patient's scalpon a second or subsequent visit, when visiting his physician todetermine the rate of hair loss, the progression of hair loss, assumingthere is any, for example, 6-24 months later.

Prior to or as a part of the methodology of the present disclosure, thebody surface 200, such as a scalp, for which the hair loss or baldnessmetric is required, is imaged. A predefined region 210, such asillustrated by either 210 a or 210 b, is subsequently identified (step110). The predefined region 210(a,b) may comprise a large area of thescalp, including regions with hair, without and regions in-between. Inone embodiment, the predefined region 210 a may be identified orgenerated by the user, for example, by freehand drawing, using forexample a mouse, stylus, pen or line tool on a touch-enabled device,tablet, or other such similar device, or by any other means known orlater developed in the art, for example, directly on the scalp or animage of the scalp. In another embodiment, also illustrated in FIGS. 2aand 2b , the predefined region 210 b may be identified using fiducials220 (which may be disposed on the patient's body surface or a deviceplaced on the body surface) prior to imaging, providing reference pointsthat are to be utilized to provide the boundaries of a predefined region210 over which a baldness metric is to be determined. The fiducials 220also may be, for example, physical markers or anatomical landmarks on apatient's skin or body surface, such as a follicular unit or hair, amole, a scar, a freckle, a wrinkle, a bump, or a depression of the bodysurface. The fiducials 220 may also be objects placed on or affixed tothe patient's skin, such a tattoo. A fiducial 220 is an object in afield of view of an imaging device that acts as a reference, and maycomprise the above or any combination thereof. For the purposes ofexplanation, FIGS. 2a and 2b also illustrate by example a predefinedregion 210 b illustrated as a square with each fiducials 220 positionedat each of the four corners of the predefined region 210 b.

Referring to FIG. 2a , once the predefined region has been identified,one or more site locations 230 may be identified (step 120). The numberof locations 230 utilized may be predetermined, selected automaticallyby the image processor, or selected by the user. In this particularexample, a 9×9 array 240 provides a total of 81 site locations 230, eachsite location 230 comprising a square with dimensions, for example, ofone centimeter squared (1 cm²). To aid in the understanding of thedisclosure, the 9×9 array 240 of FIG. 2a (representing a first instancein time T₁) has been divided into three subsets, each subset comprisingthree rows of nine squares (3×9), 250 _(T1), 260 _(T1) and 270 _(T1),the relevance of which will be discussed later. Initially, no color isassigned to any of the squares of the 9×9 array 240.

The methodology illustrated in FIG. 1 enables visualization (via a userinterface) of real time or near real time representations correspondingto values associated with unique or discrete site locations 230. Foreach identified site location 230, a determination is made of a valueassociated with the site location (step 130). In one embodiment of thedisclosure, as illustrated in FIG. 3, the value may comprise the numberof terminal hairs or hair follicles 310 within a boundary of thelocation site 230. The determination of which hairs are terminal hairs120 may be carried out by various methodologies, and comprising one ormore, or a combination, of the properties described below, determinedfor example by means of image processing. Non-terminal hair typicallyhas a caliber of less than 35 μm or less than 0.05 mm, is lighter incolor with respect to terminal hair on the same patient, and aregenerally shorter than terminal hair, for example, the average length ofa vellus hair (one example of a non-terminal hair) ranging from 0.5-1.0mm. To improve correct identification of the hair as terminal ornon-terminal, a scoring system may be employed that gives certain weightto each of the above properties (e.g., caliber, color, lengths, etc.)and based on the weighted combined score the analyzed hair may bedetermined as terminal or non-terminal. It will be apparent however,that the caliber of terminal or non-terminal hair may vary from patientto patient. Therefore, according to another aspect of the disclosure,the user may take this into consideration and vary the value associatedwith a threshold considered for a particular patient to differentiateterminal and non-terminal hair. For example, if a patient has very lighthair, then non-terminal hair may be almost translucent, or on a patientwith very thick hair, a non-terminal hair may be thicker than theaverage thickness of other patients' non-terminal hair.

For example, depending on the application and qualities of hair of aparticular individual, a terminal hair may be defined as havingthickness of greater than sixty microns. Having determined the number ofterminal hairs 310 within the boundary of the site location 230, a valueassociated with the site location 230 is thus determined (step 130), andsubsequently a representation of that value can be assigned (step 140).Representations may be in a form of a color—for example, differentcolors representing different numbers of terminal hairs within theboundary of the site location. Alternatively, representations maycomprise a shape (such as a circle, a square or a rectangle), the sizeof diameter of a dot, or any other such representation or combination ofrepresentations, which is capable of conveying a distinct meaning to theuser. In various embodiments, a particular type of representation may beautomatically provided by the automated system (e.g., a processor), orit may be defined or selected by the user, for example, via a userinterface. According to some implementations, specific representationsmay be selected or customized by user interaction with a graphical userinterface displayed on a visual display screen, by for example,utilizing drop down menus, selecting representation using text, allowingselection from a predetermined list, or by utilization of a drag anddrop methodology. In one approach, a particular color is assigned to adiscrete value or number of terminal hairs 310 that is determined to bewithin the boundaries of a site location 230.

It will be apparent that the numbers determining assignment of differentrepresentations may also vary. In the example illustrated, the colorwhite is assigned to site locations, which have fewer than 40 terminalshairs 310 within the 1 cm² site location 230. The color grey is assignedto site locations which have 40-70 terminal hairs 310 within the 1 cm²area of the site location 230, and the color black is assigned to sitelocations which have 70 or more terminal hairs 310 within a 1 cm² areaof the site location 230. These values have been selected based on thetypical number of hair, for a healthy head of hair, with respect to apatient who has had no hair enhancement treatments. For such a patient,assuming they are Caucasian, a typical number of hairs per 1 cm² areawill range from 80-140 hairs. Therefore an area exhibiting hair loss ofaround 50% will have approximately 40-70 hairs in a 1 cm² area.

It will also be apparent that the colors and values described serve asexamples only, and any color and value combination may be applied,depending upon the application in question and the desires of the user.In another example, a representation may comprise a first value if noterminal hairs are located within the site location, and a second valueif one or more terminal hairs are located within the site location. Inyet another example, rather than assigning a color to the entire area ofthe site location (the square of the array) as shown, a colored dot maybe assigned to the center 330 of the site location, the colored dotindicating the number of terminal hairs 310 surrounding it. In analternative, the actual number could appear, in a numerical format onthe screen. The methodology continues for each site location 230,thereby dynamically displaying an indication of the terminal hairs 310disposed at each site location 230.

FIG. 2a shows a representation of the body surface 200 populated (step150 of the general methodology of FIG. 1) at site locations with thecorresponding assigned representation superimposed thereon anddisplayed, for example, on a computer screen or such visual display forview by the operator.

As illustrated in FIG. 2a , the subset of 250 _(T1), the array of 9×3comprises white squares, indicating in this particular example that thearea covered by white squares is lacking terminal hairs, having fewerthan 40 terminal hairs in each identified site location, and that thepatient is effectively going bald in the region 250 _(T1). The subset ofsquares 260 _(T1), another array of 9×3 comprises grey squares,indicating in this particular example that the area covered by greysquares has 40-70 terminal hairs at each identified site location. Thesubset of squares 270 _(T1), another array of 9×3 comprises blacksquares, indicating in this particular example that the area covered byblack squares has more than 70 or more terminal hairs at each of thesite locations.

From this information, one or more metric may be determined, indicatinga level of hair loss or baldness for this patient. For example, onemetric may be one which quantifies coverage of the body surface, forexample, based on the proportion the 9×9 array which has minimalterminal hair (few than 40 terminal hairs in each identified sitelocation), which is 27 of the 81 squares, or 33%. Indicating that 33% ofthe body surface is going bald. In another embodiment, the metric may beweighted to account for the difference of hair density between array 250_(T1) and 260 _(T1), providing for a metric of hair density. Forexample, if each white square is associated with a value of 0, each greysquare is associated with a value of 1, and each black square isassociated with a value of 2, the highest value, which could be obtainedover a 9×9 array would be a value of 162. However, the value asillustrated in FIG. 2a would be 81, or 50%.

As indicated earlier, FIG. 2b is a representation of the same bodysurface 200 at a second instance in time, T₂. For example, severalmonths after a hair treatment has been applied or just several monthafter a patient's first visit. The hair treatment may comprise, forexample, the application of a hair growth enhancement product or a hairimplantation treatment in the region 250 only. The disposition offiducials allows for images to be acquired, or image processing to becarried out over the same area between the two instances in time (T₁ andT₂), enabling the image to be taken from the same distance from the bodysurface, or enabling magnification or reduction in image sizeaccordingly so that the same areas are compared. As illustrated, at T₂,the subset of 9×3 squares forming the subset 250 _(T2), comprises greysquares, indicating in this particular example that this area nowcovered by each grey squares has 40-70 terminal hairs in each square.The subset of squares 260 _(T2) also comprises grey squares, indicatingin this particular example that the area covered by grey squares has40-70 terminal hairs within each of the site locations. The subset ofsquares 270 _(T2) comprises black squares, indicating as before that thearea covered by black squares has 70 or more terminal hairs within eachof the identified site locations.

From this information, using the same metric calculations describedabove, for the first metric, after application of the hair growthenhancement product or the hair implantation treatment, there are nowhite squares or site locations having fewer than 40 terminal hairs.Therefore, after application of a hair growth enhancement product or ahair implantation treatment 0% of the evaluated body surface of interestis going bald (for example, based on our earlier explanation when fewerthan 40 terminal hairs in each identified site location being consideredas “going bald”). For the second metric calculation discussed above, theweighted metric, once again the highest value which could be obtainedover a 9×9 array would be a value of 162. However, the value asillustrated in FIG. 2b after application of the hair growth enhancementproduct or the hair implantation treatment is now 108 (or 67%). Ineither case, the metric clearly shows that there has been an improvementin the patient's hair loss condition, that his balding area (e.g., thearea with fewer than 40 terminal hairs in each identified site location)has been reduced, and the amount of hair, or hair density has increased,over the time between the first and second instances, T₁ and T₂. It willbe apparent to the reader that these examples illustrate only two waysin which a metric can be provided to measure baldness, but many othervariations of this methodology may also provide useable metrics whichare contemplated within the scope of the present disclosure.

As indicated above, the current methodology allows a complete map ormetric (e.g. baldness metric or hair health metric) to be associatedwith a patient. In addition to providing a visual indication of theprogress achieved by a procedure having been performed, the currentdisclosure also provides for the creation of a first file comprisingdata representative of one or more values associated with one or moreprocedure sites at a first time, creation of a second file of datarepresentative of one or more values associated with the one or moreprocedure site at a second time, and determining a variation orsimilarity in the correlation in the data of the corresponding sitelocations during the first and the second time. The variation orsimilarity once determined may be output in a form which conveys thisinformation on the same representation of the body surface, visually tothe physician. Alternatively, the data may be saved in another fileassociated with the patient, to be referred to at a later date.

It will be appreciated that though explained in terms of an array ofsquares, there are many other ways in which a representation of a bodysurface may be divided in order to assign representations over an area,so that a metric can be applied to hair loss. For example, asillustrated in FIG. 4, a template of defined regions associated withhair loss may be utilized, and for a particular patient, a metricassigned to each of the regions. Based on experience and/or datacompiled over time, a representation assignment associated with thevarious regions at different stages of hair loss can be determined, andutilized in providing a useful metric in terms of hair loss toindividual patients. By providing such a metric periodically (forexample, every six months or every year, depending on circumstances) toindividual patients, a physician is able to determine whether thepatient's hair loss is proceeding at a typical rate, or faster or slowerthan similar persons. Should the patient be experiencing a faster rateor hair loss, or hair loss of an unexpected or unpredicted distribution,the physician may be able to tailor the treatment plan accordingly.Alternatively, the unexpected or unpredicted rate or distribution may bean indication of a medical condition for which treatment may or may notbe available. In some situations, the metric may provide confirmation tothe patient that they are not in fact experiencing hair loss, but ratherincorrectly perceive that their hair density was higher in the past.

The classes of follicular units, density and follicle size will varyaccording to many factors, including ethnicity, so for the purposes ofdiscussion it will be assumed that our patient is a Caucasian male.Human hair emerges from the scalp in groupings, which are knows asfollicular units. Follicular units may be classified based on a numberof hairs or hair follicles (typically 1-5) in the follicular unit. Aperson with a high density of hair, typically has various quantities ofthe following classes or types of follicular units: 5-hair follicularunits (F5), 4-hair follicular units (F4), 3-hair follicular units (F3),2-hair follicular units (F2) and 1-hair follicular units (F1). As hairloss progresses, the density of hair typically reduces, with fewer or noF5 or F4 being found, with the F5 s becoming F4 s, F4 s becoming F3 s,the F3 s becoming F2 s, F2 s becoming F1 s, and some of the 1-hairfollicular units F1 s falling out. In the earlier stages of hair loss,though the number of follicular units in the area may remainsubstantially the same, the number of hair follicles in each follicularunit may begin to decrease. As hair loss progresses, the follicularunits with the higher number of hairs decrease or become zero, thefollicular units with the lower number of hair increase, and eventuallythe number of follicular units decreases also. Though the classes offollicular units may vary according to ethnicity, the progressionexperienced in hair loss is the same.

FIGS. 2c-2f illustrate examples of some alternative displays andrepresentations of information related to the metric of hair health (orhair loss), as may be displayed to the user, for example, on a computerscreen or a display of a mobile device. In some embodiments, thephysician may utilize a computer screen, mobile device, tablet,smartphone or other visual display to which an image acquisition device(for example, a digital camera incorporated into a mobile telephone, amicroscopic lens, such as a ProScope mobile microscope camera fromBodelin Technologies, or other such microscopic lens or camera) can beattached. Hair Simulation Software according to this disclosure may bedownloaded, for example, onto the mobile device in the form of asoftware application, as is the case for many other commercial softwareproducts or “Apps”. Armed with the mobile device, preloaded with theHair simulation software, with the microscopic lens attached, thephysician is now in possession of all he needs to be able to show apatient their potential hair loss of hair gain in a format which is moresuitable for the understanding of that patient.

The physician may begin by creating a new or unique record using theHair Simulation Software, in which details on a particular patient canbe input. In some instances, this record may be created prior to thepatient's consultation session by the administrative staff, making themost use of the physician's time with the patients, rather than onadministrative tasks. The details of the record may include for examplethe patients name, current age, date of birth, gender, contactinformation etc., details relating to the current visit or currenthealth of the patient, medications, health history and/or familyhistory, as well as information, such as, hair color, skin conditions,just to name a few. The physician may utilize existing features of themobile devices, such as the camera or electronic mail features toadditionally input photos, videos, test results, notes or other suchinformation in a unique record for this particular patient. In otherinstances, the new record may be created on a separate computer system,and synchronized with the data on the mobile device.

Having created the patient's record, the physician may utilize themobile microscope camera attached to the mobile device, along withassociated software application, to capture a still image of one or morepredetermined areas of the patient's scalp, and optionally store theimage(s) in an image repository, or image library on the mobile device.Such images may comprise an image of the actual hair follicles, whichhave been magnified by the mobile microscope. The physician mayalternatively, or additionally, associate and/or store any capturedimage(s) in association with the patient's record that were previouslycreated, optionally including any notes, comments or information, ifdesired, for referring back to at a subsequent time. In someembodiments, the physician may access previous images associated withthe patient and display one or more such images, for example,simultaneously, with the current image(s). In this manner, the physicianmay be able to image substantially the same area of a patients scalp atdifferent times, and sequentially or simultaneously display a currentimage and an image captured 6 months, a year, or even more ago, therebyenabling the patient to see the status of the hair loss or gain, or thatthat there has been substantially no change. The physician or other usermay utilize some method of ensuring that the same area(s) is/are imaged.For example, one may utilize fiducials, such as physical markers oranatomical landmarks on a patient's skin or body surface, e.g., afollicular unit or hair, a mole, a scar, a freckle, a wrinkle, a bump,or a depression of the body surface, as previously discussed. Thefiducials may also be objects permanently or temporarily placed on oraffixed to the patient's skin, such a tattoo. As indicated previously, afiducial is an object in a field of view of an imaging device that actsas a reference, and may comprise the above or any combination thereof.

Optionally, the image processing techniques may be utilized to determineinformation, which may not be apparent to the naked eye, whether theimage is magnified or not. An image processing component, module orsystem may be incorporated into or used in combination with a computer,the mobile device, tablet, smartphone or other such visual displaydevice, or peripheral associated therewith. The image processingcomponent, module or system may automatically analyze an image capturedvia the microscopic lens to determine one or more attributes of thefollicles, using image processing techniques known to those skilled inthe art, including, but not limited to, image cropping, imagesegmentation, thresholding, distortion and contour detection techniques.The image processing may differentiate the hair follicles from thescalp, determine the color of individual follicles, their length, width(or caliber), location at which they come out from the scalp, directionand/or orientation, and the distance from a selected hair to a nearesthair.

In one implementation, the acquired magnified image may be cropped suchthat only a region of interest is analyzed. Predetermined calibrationparameters may be utilized to correct for distortion in the image, andappropriated grayscale and thresholding techniques applied to furtherclarify the image, determining portions associated with hair folliclesfrom the patient's scalp. At this stage, optionally, contours may bedetermined and hair follicle classification (the number of hairfollicles in a follicular unit) may be also evaluated. Classificationtechniques are described, for example, in commonly assigned U.S. Pat.No. 7,477,782 entitled “System and Method for Classifying FollicularUnits”. In this manner various parameters or data can be determined orcalculated, including, but not limited to the density of hair follicleswithin the region of interest, the caliber of the individual hairs orthe average thereof, and the length of the individual hairs or theaverage thereof.

According to another aspect of the present disclosure, as stated above,simulation of potential hair growth or potential hair loss of a subjectover time may be displayed, for example, on a computer screen, mobiledevice, tablet, smartphone or other such visual display. Such displaymay be viewed by a patient or by any party involved in the treatmentplanning. Such simulation based upon the patient's actual hair inreal-time enables a physician or hair loss specialist to providepatients with a more realistic simulation of their hair in the comingmonths or years. Whether it is to show the patient what the density ofhair might be if they were to have a hair transplantation, or to showthem what they would look like in another 6 month, based on their hairloss experienced over the past 6 months, the simulation could beprovided during the patient's visit, allowing patients to view theircurrent status alongside the potential future status.

The hair simulation component, module or system, comprising imageprocessing capabilities may be utilized to simulate hair growth byadding one or more simulated hair follicles, or to simulate hair loss byremoving one or more of the imaged hair follicles within the processedarea. In either case, the simulation may be based on the actualreal-time imaged and, optionally, magnified hair follicles on thepatient's scalp. The simulation algorithm may utilize informationacquired based on the actual hair follicles imaged to suggest, forexample, the locations of potential implantation sites, the color of thesimulated hair, its length and its caliber. In some embodiments, asampling of one or more hair follicles in the region of interest isduplicated, and hair may be simulated by replicating one or more of theduplicated hairs. In this manner potential hair growth or an increase inhair follicle density can be illustrated. The simulation algorithm mayalso suggest locations from which hair follicles should be removed fromthe image, thereby illustrating potential hair loss or a decrease inhair follicle density. Image processing techniques known by those in theart may be utilized to blur or fade existing imaged hair, for example,modifying the element values of a kernel or convolution matrix to maskor fade the existing hair, or replace it with a transparent version,thereby simulating the removal of one or more hair follicles.

The Hair Simulation Software application mentioned earlier may comprisea user-interface enabling the physician and/or patient to view progress(positive or negative) and/or generate various simulations. FIGS. 2c and2d illustrate one example of such an interface. In one embodiment, theuser interface screen (for example, of the mobile device) may comprisefunctionality for selecting a particular historic or current image aswell as a location where such image may be inserted/displayed. Assuminga touchscreen type device is utilized, the user may tap the locationinto which an image may be inserted, for example, selecting the top lefthand side location illustrated in FIG. 2c . Similarly, tapping an imageselection icon 272 “Choose Image”, for example, facilitates access of arepository of previously stored images, preferably images associatedwith this particular patient. As indicated earlier, this repository mayreside on the mobile device itself, or at another location, for exampleon portable data storage devices (for example, a USB drive), a localcomputer hard drive to which the mobile device is typicallysynchronized, or to a remote media-sharing environment, such as theCloud, to which the device can connect via the internet. FIG. 2cillustrates the on the left hand side of the display an image selectedby the user, in this case a current image 274 representing the currentstatus of the patient. In another embodiment, an algorithm residing inthe Hair Simulation Software may have a default condition, whichautomatically selects the latest image acquired into the top left handside location. Having made the selection, or once the default conditionhas been met, a “Calculate Density” icon 276 is selected, which promptsan underlying algorithm within the image processing module to identifythe hair follicles within the image, and compute a number of parameters,such as the number of hair follicles or follicular units, an area ofpotential implantation, an average density of hair follicles (orfollicular units) within a unit area, an average caliber valueassociated with the imaged hair follicles, and an average hair folliclelength. The results of these calculations may be displayed for viewingby the user in a data area 278. In another embodiment, once the imagehas been selected, these computations may automatically be carried outand displayed for the user to view without the need to choose anyparticular icon or button.

FIG. 2c illustrates on the right hand side of the display one example ofan implementation of how simulation of hair loss is depicted accordingto present disclosure. Initially, the image location on the top righthand side of the interface may be automatically populated with the imagefrom the top left hand side of the interface, providing an indication ofwhat that area would look like if nothing changed, if no hair loss wasexperienced (in other words, the image from the left hand side may beduplicated on the right hand side). Then the appearance of hair in suchimage may be adjusted, for example, based on the desired density ofhair. The user may adjust the number of hair follicles that appear inthe simulation image 280, by providing input via for example a slidingbar mechanism 282. In one embodiment, initially, the slider of the slidebar may be substantially in the middle of the bar, enabling the user tomove the slider to the left to show reduction of the follicular unitdensity, or to the right to increase the follicular unit density. Itwill be appreciated that the slider bar is just one example of a userinterface that may be utilized for this purpose, and otherconfigurations may be adopted, for example the use of up and downarrows, or by actually entering a value with the respect to the densityvalue desired as a percentage of the initial value, or in terms of anactual number of follicular units desired per unit area. Adjusting thevalue of the desired density using the slider bar 282 to demonstratehair loss as illustrated in FIG. 2c , correspondingly adjusts or revisesthe simulation image 280 by reducing the number of follicular units thatappear in the simulation image 280. As indicated earlier, a simulationalgorithm may remove one or more hair follicles or follicular units fromthe simulation image 280, utilizing image processing techniques known bythose in the art to blur or fade existing imaged hair, for examplemodifying the element values of a kernel or convolution matrix to maskor fade the existing hair, or replace it with a transparent version,thereby simulating the removal of one or more hair follicles 284. Thenumber of total hair follicles lost may be identified in a total hairloss field 286. To ensure that the simulated hair loss is realistic(e.g., the reduction in hair does not all shown to occur in a localizedarea or all hair that are left after reduction do not form unwantedgeometric patterns, for example straight lines), follicular unit densityreduction algorithms can be utilized, such as found in commonly assignedU.S. Pat. No. 8,945,150 entitled “Systems and Methods for Selecting aDesired Quantity of Follicular Units”, or commonly assigned U.S. PatentPublication Number US 2016/0030075 entitled “Systems and Methods forCreating Hair Transplantation Procedure Sites”, which are herebyincorporated by reference.

FIG. 2d illustrates on the right hand side of the display animplementation of the disclosure in which simulation of hair gain isdepicted. As before, initially, the image location on the top right handside of the interface may be automatically populated with the image fromthe top left hand side of the interface, providing an indication of whatthat area would like if nothing changed, if no hair gain wasexperienced. The user may adjust the number of hair follicles thatappear in the simulation image 288, by providing input via for example asliding bar mechanism, sliding the slider 290 to the right to increasethe follicular unit density. The increase in the number of total hairfollicles 292 may be simulated by replicating one or more previouslyduplicated hairs, and the number of hair follicles added may beidentified in a “Total New Hair to Implant” field 294. Typically, aphysician creates a simulation of hair gain to show a patient what anarea currently somewhat devoid of hair could look like should a hairtransplantation or other hair loss treatment be carried out.Realistically, the implantation of hair, whether it is by means of amanual or an automated/robotic procedure, has certain limitations as towhat can ultimately be achieved. These limitations are associated withvarious factors, including the actual availability of hair in the donorarea, as well as the physical limitation of the implantation procedure.For example, consideration is typically given to how close hair may beimplanted to existing or previously implanted hair without causingdamage to the existing or previously implanted hair, where hair may beimplanted based on the physical limitations or sizing of the tool, aswell as aesthetic considerations. In addition, should a hairtransplantation be considered, consideration need also be given to thenumber of hairs available for harvesting from a donor area and theirassociated classifications. Based on various factors, such as one ormore of those provided by example above, the Hair Simulation Softwaremay be configured such that should a requested density be above what canbe realistically achieved, the software will limit the increase indensity to what is potentially achievable. Alternatively, should thedesired density require the addition of 31 new hairs, but there are only20 available, the physician will be able to see this information via theuser interface. In this manner, a realistic simulation can be achieved,based on a potential procedure that may be performed.

As indicated earlier, according to another aspect of the disclosure, theuser may wish to see, side-by-side, the current status compared to avisit made to the physician at an earlier date, for example 6 months ora year prior. In this situation, the interface may enable the user toadopt a process similar to the process the user utilized to select theinitial status image 274 now to select another previously stored imageof the same location but from a different point in time. The user mayselect the location of the top right hand image (280, 288) and thenselect the image selection icon 272 to facilitate access to therepository of previously stored images, preferably images associatedwith this particular patient from previous office visits, 6 months, ayear or more ago. Once a previously stored image has been selected, aCalculate Density icon similar to that of 276 is selected, which promptsan underlying algorithm within the image processing module to identifythe hair follicles within the image, and compute a number of parameters,such as the number of hair follicles, the number of follicular units, anarea of implantation, an average density of hair follicles (orfollicular units) within a unit area, an average caliber valueassociated with the imaged hair follicles, and an average hair folliclelength, and others. The results of these calculations may be displayedfor viewing by the user on the right hand side of the user interfacenext to the relevant image that was analyzed. In some embodiments, oncethe previously stored image has been selected, these computations mayautomatically be carried out and displayed for the user to view.

In some instances, the physician or user may find it useful to highlightthe simulated hair that has been added. This may be accomplished, forexample, by a toggle switch 296 on the user interface. Highlighting thesimulated hair may enable the patient in particular to appreciate whereadditional hairs are suggested to be added, and to visualize whatcontribution what such a number of additional hairs makes.

In a further aspect of the present disclosure, various individualfeatures/information about the displayed image and hair (or acombination of features) may be highlighted to the user. Once an imageis selected, for example, the current status image 274, the user mayselect via one or more additional toggle switches 298 (or otherselection mechanisms), one or more particular or additional features tohighlight. In FIG. 2e , for example, such additional feature that may behighlighted is the type of class of follicular hair (e.g., whether it isF1, F2, . . . ). It can be seen that the toggle switch 298 correspondingto the highlighting of F1 type follicular units has been selected, whichinstructs the software to highlight the F1 type follicular units 300 tothe user, for example, by changing their color to blue perhaps. In FIG.2f , the toggle switch 298 corresponding to the highlighting of vellustype follicular units has been selected, which instructs the software tohighlight the vellus type follicular units 302 to the user, for example,by changing their color to red perhaps. In another embodiment, the usermay select more than one toggle switch 298, and highlight perhaps allfollicular unit classification types, but not the vellus hair, or usingdifferent color highlights for each type. This information may bebeneficial to both the physician and the patient. For example,highlighting F1 type follicular units that are typically used to restorea front hairline, provides information on whether there are sufficientF1 type follicular units to utilize for transplantation into the fronthair line, thereby enabling both a patient and a physician to make moreinformed decisions.

In certain embodiments, the use of the existing characterization and/orclassification techniques can be extended such that should the userselect a particular hair within the image, such selection instructs thesoftware to determine one or more characteristics of the selected hair.These characteristics may be conveyed to the user in the appropriatefields 304, indicating for example the caliber, length and/or distanceto the nearest hair.

Systems and methods of the present disclosure provide physicians with adynamic real-time detection and simulation tool, which can be used tooptimize the information that can be conveyed to any patient in arelatively short period of timed. This information may also be utilizedin the planning of any future hair transplantation procedure, showingthe patient what the density of the hair can look like based on theactual real hair, potentially serving as an initial indicator of whetherthere is sufficient hair to transplant in the desired regions, and alsoproviding a potential indication of the associated cost of such aprocedure.

In this manner, a metric of hair loss can be provided, enabling thepatient to attain a visual understanding which may not be readilyapparent by eye, and providing a quantitative measure of hair lossprogression, or regression. It will be apparent that the methodologiesand embodiments discussed in reference to the metric of hair loss withthe aid of FIG. 1-3 may be combined with the methodologies andembodiments discussed with respect to FIG. 5, FIG. 6 or FIG. 7 below,and various combinations are contemplated.

Hair Loss Management Tool

The present disclosure also provides a methodology by which a physiciancan provide a patient with a personalized treatment plan, based onmetrics which provide information on the classification, distributionand/or density of follicular units for the specific patient, thusproviding the patient with a personalized plan based on the actual hairon his head. This aspect of the disclosure utilizes the mechanics ofhair loss, determines the dynamic change in proportions of follicularunits to ascertain, for example, if and/or when a hair loss treatmentshould be initiated to achieve more favorable results.

FIG. 5 is a block diagram illustrating an example of acomputer-implemented method for determining and managing hair loss,including a general methodology 500, for predicting a rate ofadvancement to a next stage of a hair loss value. For example,predicting the rate of advancement of hair loss that may be accomplishedin a predetermined time increments, such as 3 month increments, or otherdesired time intervals. A computer-implemented method illustrated inFIG. 6, may utilize some of the steps similar to those shown inreference to FIG. 5 and such method may assist in determining andplanning if and when a hair transplantation procedure or other suchprocedure should be undertaken. Using these methodologies, a physicianis able to suggest to a patient the available options, and potentiallywhat the next step should be. Potential suggested actions may include,for example, a recommendation “to do nothing”, but come back again in afew months to track progress; to commence with a hair treatment plan,such as application of an ointment or other such solution to minimizehair loss; or perhaps consider undergoing a hair transplantation, and ifso, when. These methodologies determine what action to adopt withrespect to the stage of hair loss, and associated hair loss factors,managing the expectation of the patient as to what can be actuallyachieved based on the determined rate of hair loss, and classes offollicular units available at a relevant time.

As a preliminary matter, in step 505, one or more images of a bodysurface may be obtained, acquiring image data, for example, by using animage acquisition or imaging device, or any other technique known in theart. In other embodiments, the image data can be created in real-time,using a digital camera. For example, in some embodiments an imageacquisition device may be attached to a robotic arm. In otherembodiments, the image acquisition device may be still incorporated intothe automated (e.g., robotic) system but it does not have to be attachedto the robotic arm. Alternatively, in further embodiments, the imageacquisition device could be a device separate from the robotic system.Once an image has been acquired, one or more regions of interest, forexample areas of hair and areas of bald scalp can be identified (step510) using various methodologies, including for example, through use ofsegmentation, contouring, edge recognition and other known imageprocessing techniques. In this manner, if applicable, one or more areassuch as a frontal region 410, a forelock region 420, a mid-scalp region430, a crown/vertex region 440, or a lateral fringe region 450 can beidentified. In the case of a patient who is already experiencing hairloss, the identification of regions of interest may include both areaswith hair (potential donor areas) and with less or without hair(potential recipient areas). For purposes of hair transplantation,typically the back of the head is utilized as a donor area, though hairmay be harvested from other regions depending on the patient, and theirdistribution of hair. The general methodology of FIG. 5 may include anoptional step 520 that may be implemented in some of the embodiments. Insuch optional step 520, based on the identification of a particular setof regions, as known to those skilled in the art, a hair loss value maybe assigned using any appropriate technique. For example, the hair lossvalue may be assigned by matching the actual identified regions of aparticular patient to those predetermined or otherwise known asrepresenting a particular stage of hair loss. In one embodiment of thedisclosure, the assignment of hair loss value may be based on theNorwood scale of hair loss for male patterned baldness, though otherscales may be used. A pattern-matching algorithm can be used torecognize the hair pattern and match it to one of a series of images ina repository, for example, to assign a corresponding value of hair loss.In those embodiments where the value of the hair loss is assigned, suchdetermined value may be used as described later below.

In step 530 a proportion of terminal or non-terminal hair is determinedin each regions of interest. Typically, a proportion of non-terminalhair of greater than 20% is an indication that a hair loss process hasstarted and that a person has a condition referred to as an androgenetichair loss. In various implementations, it may be determined, forexample, which hair in the region of interest or certain portion of theregion of interest are terminal and which one are not, and based on thatinformation it may be further determined the relevant proportions ofeither terminal or non-terminal hairs (determination of the proportionof one would simultaneously provide a corresponding proportion for theother). In other words, determining whether a condition of androgenetichair loss exists may be done by determining either the proportion ofterminal or non-terminal hairs in the area. Identification of terminaland/or non-terminal hair may be carried out by various available means,including as described earlier in reference to FIG. 1 and discussionabout the metric of hair loss.

The determination of non-terminal hair (such as vellus hair, dying,miniaturized, or non-regenerating hair), is useful because it allows toestablish in a first place whether a person actually experiencing hairloss, as stated above. In addition, it is useful because non-terminalhairs are deemed unrecoverable, an effect associated with male patternbaldness. Hence non-terminal hair does not need to be taken into accountdue to the fact that it will eventually fall-out or disappear and willnot aid in the overall look achieved once a hair implantation procedureis performed, or other such treatment is applied. The classification ofterminal and non-terminal hair (vellus or miniaturized) provides a meansby which terminal or healthy hairs can be included to form part of thedensity of hairs in the region of interest, and non-terminal hairs canbe excluded in the calculation of the density of hair in the region orarea of interest. It will be appreciated that potential recipient areaswith a higher number of terminal follicles or hair will require lessimplantation sites than recipient areas with a higher number ofnon-terminal hair, and similarly potential harvesting areas with ahigher number of terminal hair will produce more donor sites and hairgrafts available for harvesting. So for planning purposes, whenanalyzing a region of interest which is a potential recipient region orarea, non-terminal hair does not need to be counted and included in theanalysis of classes of follicular units as described below. Similarly,in some embodiments, the classification analysis may be performed in theregions of interest that could be used as donor areas for harvesting topredict and evaluate how much and what types of hair will be availablein such potential donor area for harvesting in the future.

Typically when progressive hair loss begins, the rate at which hair willbe lost will depend of various factors, some of which were discussedearlier. The natural distribution of follicular units in an averageCaucasian male is approximately 20% of F1, 40% of F2, 30% of F3 and 10%of F4 and higher (F4+), with an error margin of about +/−10%. Asdiscussed above, as hair loss progresses, the higher value follicularunits disappear, and the lower values increase in numbers, untileventually they all disappear. However, people of different ethnicitiesmay have a different typical thickness of hair, or different typicaldistributions of various classes of hair. For example, in an Asianpopulation, the individual hair follicles are typically thicker than ina Caucasian population, and F4 and F5 classes of hair are rarely found,even in a healthy person who does not exhibit any hair loss. Therefore,it was discovered that the distribution of classes of follicular unitsin a particular person without the knowledge of what represents aterminal hair for such person and whether the hair loss process hasstarted, may not by itself provide an accurate picture of the state ofthe hair health or hair loss. Therefore, determining the proportions ofterminal and non-terminal hair (and hence, whether the hair loss beginto occur) may provide a point of reference and improves the accuracy ofthe analysis of the distribution of classes of the follicular units asfurther described. For example, presence of hairs or follicles ofdifferent caliber is typical of androgenetic alopecia and reflectsprogressive hair miniaturization due to the disease. A diversity ofgreater than 20% of hair caliber is diagnostic of androgenetic alopecia.

Having determined the proportion of the terminal or non-terminal hair instep 530, the follicular units in the regions of interest (for example,regions that may be identified as potential recipient areas) areanalyzed in step 540. The analysis 540 may comprise segmenting the imageof the recipient area to recognize the hair, as well as using variousknown image processing techniques, for example edge detection, objectrecognition and selection. In step 540, a proportion of follicular unitbelonging to each of the types or classes (e.g., F1 to F5) in the areasof interest, for example recipient areas, may be analyzed, with analysiscomprising identifying the classification, or classes of the follicularunits, identifying the caliber of the hairs, adjusting theclassification of follicular units based on the caliber of hairs toaccount for hair which is non-terminal, and determining a follicularunit distribution over the area of interest. Assuming that thedetermined proportion of non-terminal hair was less than 20% or thedetermined proportion of terminal hair is 80% or above (within thenorm), and if the analysis of follicular units described in step 540above reveals that four or more types or classes of follicular unitswere present, (that is comprising F1 s, F2 s, F3 s and F4+s) and thattheir distribution was approximately 20% of F1 s, 40% of F2 s, 30% of F3s and 10% of F4+s, +/−10%, such area (of the region of interest) wouldbe identified with a high score and ranked, for example, as an A-typearea. The A-type area would denote a healthy or stable region that isnot associated with a progressive hair loss, and unlikely to require ahair implantation any time soon, or at least, for example, in the next12-36 months. Should the same potential recipient area have a proportionof non-terminal hair of greater than 20% (or terminal hair less than80%), and comprise substantially only three types or classes offollicular units, that is F1 s, F2 s, and F3 s, with a negligiblequantity of F4 or higher follicular units, for example 22% of F1 s, 44%of F2 s, 33% of F3 s, and only 1% or less of F4, this would correspondto a lesser score, ranked for example as a B-type area and denoting aregion or area which was showing signs of hair loss, with a slightreduction of hair density. This type of area may be indicative of onethat is somewhat likely to benefit from a hair implantation, forexample, within a time frame of 12-24 months, or a longer period, as maybe appropriate under circumstances. Likewise, should it be determinedthat proportion of non-terminal hair was greater than 20% or thedetermined proportion of terminal hair is 80% or less and the potentialrecipient area comprise substantially only F1 s and F2 s, with anegligible or no quantity of F4+, and a significantly reduced proportionof F3 (a reduction of 30% or more), for example 31% of F1 s and 63% ofF2 s, 5% of F3, and 1% or less of F4, it would correspond to a C-typearea, denoting a region which was showing a more pronounced sign of hairloss. Such C-type area may indicate that it is likely that the areawould benefit from a hair implantation, for example, within a time frameof 9-18 months, or in some cases 3-6 months, or other appropriate timeframes. Finally, should the same potential recipient area have aproportion of non-terminal hair of greater than 20% (or terminal hairless than 80%), and a recipient area comprise substantially only F1 sand F2 s, with a negligible quantity of F3 and no F4, for example 65% ofF1 s and 34% of F2 s, and 1% or less of F3, it would correspond to aD-type area, denoting a region which may benefit from a hairimplantation, for example, within a time frame of 6-12 months, or evensooner, for example within the next 3 months. Therefore, based on theabove analysis of the proportion of non-terminal or terminal hair andthe distribution of various classes of follicular units enables aprediction of advancing to the next stage of hair loss to be determined.In one embodiment a prediction of hair loss may be determined forexample, based on a higher proportion of lower classes of follicularunits, and the lack of higher classes of follicular units. Moreover,based at least on two (or more) measurements on the same patient made attwo points in time separated by a predetermined amount of time (forexample, 3 to 6 months, however, any other appropriate time frame may beused depending on a particular case), one may determine a rate ofadvancement of the hair loss. Furthermore, based on the known statisticsand historic data for various types of patients (with reference, forexample, to ethnicity, age, race, etc.), a prediction may be calculatedand made with respect to the rate of advancement of the hair loss for aparticular patient. Also, a combination of the historic data with the atleast two spaced apart in time measurements for a particular patient maybe used in determining a rate of advancement of hair loss. For example,Patient 1 and Patient 2 (both with the same original distribution of theclasses of hair at the time of first measurement) at the time of thesecond measurement showed the following results: Patient 1, a Caucasianmale, had 60% of F1 s and 40% of F2 s, and no F3 s or F4 s and Patient2, also a Caucasian male had 40% of F1 s, 50% of F2 s, and 10% of F3 s,with no F4 s. As a result of comparison, one could determine that thehair loss of Patient 1 was progressing to the next stage of hair lossfaster than the hair loss of Patient 2 Based on data from previouspatients, in some embodiments, the physician may be able to predict atime for the progression of such hair loss. In other embodiments, theproportion of follicular units, in combination with the density of hairfollicles within a predefined region, may enable a determination to bemade as to the rate of hair loss. For example, in a case of Caucasianmale, with 60% of F1 s and 40% of F2 s, and no F3 s of F4 s, and thetotal number of hair follicles being less than 50 hairs per cm², onecould determine that the patient's hair loss was progressing such thatthe next stage of hair loss would be reached within a time frame ofapproximately a year. For the same patient, should the total number ofhair follicles be more than 100 hairs per cm², one could determine thatthe patient's hair loss was progressing such that the next stage of hairloss would be reached a longer time frame of, for example a 2-3 yeartime frame.

This information ultimately providing data for planning if and/or whento undergo a hair treatment plan, or if and/or when to undergo a hairtransplantation procedure. As will be appreciated by those skilled inthe art, in various implementations and depending on a particularpatient, a different number of area types A, B, C etc. may be defined,as well as the particular characteristics of each such area. Similarly,different ranges of the suggested time frames for performing treatmentmay be associated with each such defined type of area A, B, etc. Also,in some embodiments, where the hair loss value was assigned during theprocess, the method may further comprise a step of predicting andreassigning the value of hair loss as of a future date based on thepredicted rate of advancing of hair loss.

According to another aspect of the disclosure a rate of progression,advancement or even regression of hair loss can be determined, the ratedetermined by carrying out the methodology illustrated in FIG. 5 two ormore times over an extended period of time, the time being from 6-24months, for example.

FIG. 6 is a block diagram illustrating an example of acomputer-implemented method for analyzing the existing proportion ofhair types on a body surface to plan and manage potential treatments andthe expectation of a result that can be achieved by such treatment,including if and when the hair transplantation procedure should beundertaken. It will be apparent that many of the steps of FIG. 5 may beimplemented in the methodology of FIG. 6.

As a preliminary matter, in step 605, one or more images of a bodysurface may be obtained, acquiring image data, for example, by using animage acquisition or imaging device, or any other technique known in theart. Once an image has been acquired, regions of interest, for exampleareas of hair and areas of bald scalp can be identified (step 610)through use of segmentation, contouring, edge recognition and other suchknown image processing techniques. Having determined proportions ofterminal and/or non-terminal hair in relevant regions of interest (step620), the follicular units in the regions identified as potentialrecipient areas and potential donor areas are analyzed (steps 630 and650 respectively).

The analysis 630/650 comprises determining a distribution of follicularunits found in each of the respective potential recipient and donorareas. The analysis 630/650 may comprise one or more of the modulesidentified by dotted lines, with the particular results from each modulecontributing to the one or more actions that can be proposed in module670. In some instances, certain of the one or more modules may have agreater contribution to the one or more actions proposed in 670,implemented by a weighting factor. In some embodiments, the analysis of630 and 650 may require entry in step 632 of the ethnicity of thepatient, as classes of follicular units, density and caliber, forexample, vary according to ethnicity. Various steps of the analysis of630 and/or 650 may be implemented using various image processingtechniques, including, for example, image segmentation. Some of theExamples of modules that may be used in the analysis 630 or 650 includedetermination of density (636,656), identifying classes of follicularunits (638, 658), identifying hair caliber (640, 660), etc. In referenceto the optional module of identifying hair density, the results of suchdensity determination may dictate if certain treatment plans are anoption. For example, if it is determined in step 656 that there isinsufficient density of hair in a donor region to harvest for subsequentimplantation, this determination will result in the methodologydetermining an option other than suggesting a hair transplant to thepatient. Hair transplantation cannot be recommended as an option to apatient with insufficient density of hair in a donor region, as furtherdepletion of hair in this region will only increase the appearance ofbaldness in that region. For example, some physicians consider that adensity of fewer than 20 grafts in a 1 cm² area or an average of 40hairs per 1 cm² area (assuming that F2 s to be an average), is too lowfor hair transplantation to be an option.

In some embodiments, analysis may comprise identifying theclassification or classes of the follicular units (steps 638/658), andidentifying the caliber of the hairs (steps 640/660). The result of theidentification of terminal and non-terminal hair (step 620) mayadditionally be used in the determination of density (steps 636/656),with terminal hair being used to calculate the density of hairs in therecipient region, the non-terminal hairs being excluded in thecalculation of the density of hair in the recipient region.Additionally, the result of the classification of terminal andnon-terminal may be utilized in adjusting the classification offollicular units, accounting for hair which is non-terminal based on thecaliber of hairs. In one embodiment this may comprise determining anumber of follicular units in each class taking into considerationexistence of terminal and non-terminal hair, wherein each class is basedon the number of hair follicles in a follicular unit. In step 642/662,the follicular unit distribution over the recipient/donor areas may bedetermined.

An example of the determination of the distribution of follicular unitsover the recipient areas was discussed above in reference to FIG. 5. Ina similar manner, if it were determined that four or more classes offollicular units were present in a donor area of region of interest andthat the distribution of follicular units was approximately 20% of F1 s,40% of F2 s, 30% of F3 s and 10% of F4+s, +/−10%, assuming thatminiaturization was less than 20%, then such donor area would be rankedwith a high score, for example as an A-type area, and denoting a regionwhich did not appear to be moving to the next lower stage of hair lossvalue, thus providing a good resource as a potential donor area. Shouldthe same potential donor area comprise substantially only threefollicular unit classification types, that is F1 s, F2 s, and F3 s,+/−10%, with a negligible quantity of F4+, for example 22% of F1 s, 44%of F2 s, 33% of F3 s, and 1% F4, and a proportion of non-terminal hairof greater than 20% (wherein an increase of non-terminal hair sometimesmay be referred to as miniaturization), this would correspond to alesser score, ranked for example as a B-type area, denoting a regionwhich was showing signs of hair loss, and a slight reduction of hairdensity. Such region may be automatically ranked by the system aspossible but less favorable choice for a donor area, giving priority forpotential future harvesting to the region ranked as type A. Of course,if desired, such automated order of preference may be adjusted oroverridden by the user if some other additional considerations make thistype B area a better region for potential hair harvesting than theregion ranked as A type based on the above analysis. In another example,should same potential donor area comprise substantially only F1 s and F2s, +/−10%, with a negligible quantity of F4+ and a significantly reducedproportion of F3 (a reduction of 30% or more), for example 31% of F1 sand 63% of F2 s, 5% of F3, and 1% of F4, it would correspond to a C-typearea, denoting a region which showing more significant signs of hairloss, and therefore, not necessarily a good donor area. In fact, as aresult of the analysis according to the methodology of FIG. 6, suchinitially identified potential donor area may be reconsidered aspotential recipient area. Finally, should a donor area comprisesubstantially only two follicular unit classification types, that is F1s and F2 s, with a negligible quantity of F3 and no F4, for example 65%of F1 s and 34% of F2 s, and 1% of F3, it would correspond to a D-typearea, denoting a region which should not be chosen as a donor area. Itshould be noted that the above examples are based on a Caucasian malepatient. Should the ethnicity differ, being Asian, for example, adistribution of only F1 s and F2 s in the region of interest while theproportions of the terminal hair correspond to the typical standardnumbers for healthy hair, as a result of the analysis such region may beidentified as the type A or B and utilized as donor area, since thisparticular ethnic group generally has a lesser occurrence of F3 and F4.

Having determined whether conditions of beginning of hair loss arepresent in step 620 (for example, by determining proportions of theterminal and/or non-terminal hair), and subsequently analyzed theproportions of classes of the follicular units in each of the donor andrecipient areas, step 670 of the method may propose one or more actionsthat may be available to the patient, suggesting, for example, the mostsuitable options available based on the data collated, including thedistribution of follicular units in both the recipient and donor areas.In this manner, by proposing one or more actions, the physician is ableto manage the expectation of the result that can be achieved by, forexample, suggesting which region of the scalp it is recommended thathair be implanted into, such as a hairline, or the mid-scalp area, toperhaps achieve the best distribution of hair over the recipient anddonor areas, given the limited supply of donor hair. As discussed above,this determination may be based on the identification of follicularunits, hair density, hair caliber, determining a proportion ofminiaturization, adjusting the follicular unit classification to accountfor non-terminal hair (such as taking into consideration existence ofterminal and non-terminal hair when determining the class of follicularunit, each class based on a number of hair follicles in a follicularunit), and the distribution of follicular units within the donor andrecipient areas. The compilation of all this information ultimatelyserving as data for planning if and/or when to undergo a hair treatmentplan, or if and/or when to undergo a hair transplantation procedure. Insome embodiments, an initial hair loss value may be assigned to thescalp and this information may be also taken into consideration in theabove determinations and decisions. It will be apparent that the systemand tools used in performing the methodology described may be customizedand configured such that the software may be tailored to incorporate aphysician's preference as to what action be taken, what options shouldbe suggested, and when such action should be performed. Suchcustomization may be based on a physician's particular experience,existing data, the physician's practice capabilities, and/or anycombination of the above. In an alternative, a pre-configured set ofdeterminations may be utilized and presented in an automated manner. Thesystem may be further configured to allow the user to modify or overrideany automated options proposed by the system.

Some examples of how an automated system may be configured or programmedto provide automated determinations are provided below. It should beunderstood that many alternative implementations are within the scope ofthe present disclosure.

-   -   Assume that the density of hair in the recipient areas is less        than 50 hair per cm², and that it is determined in step 630 that        the distribution of follicular units in the recipient areas is        approximately 70% of F1 s and 30% of F2 s, so that the recipient        area is characterized as a D-type area. Based on this        information, one would assume that hair transplantation should        be recommended. However, if step 650 should determine that the        distribution of follicular units in the donor area(s) is        approximately 65% of F1 s and 34% of F2 s, and 1% of F3, also        corresponding to a D-type area (no sufficient donor area        available for harvesting), the system may determine based on the        results of steps 620, 630 and 650 that, for example, no hair        transplantation should be considered by the patient due,        primarily, to the lack of hair in the donor area. The        corresponding analysis and logic may be programmed into the        decision tree for the automated determination and proposal of        potential options.    -   Similarly, if in step 620 it is determined that the proportion        of non-terminal hair is greater than 20% (an indication of        androgenetic hair loss), and in step 630 that the distribution        of follicular units in the recipient areas was approximately 70%        of F1 s and 30% of F2 s, corresponding to a D-type area, from        the data provided by step 630, once again one may assume that a        hair transplantation should be recommended. Then, if in step 650        it should be determined that the distribution of follicular        units in the donor areas is approximately 20% of F1 s, 40% of F2        s, 30% of F3 s and 10% of F4, (with a density of 60 hairs per        cm² or more) corresponding to a A-type area, such donor are will        be identified as an acceptable donor area. The system may be        programmed accordingly such that the compilation of steps 620,        630 and 650 results in a determination that a hair        transplantation should indeed be considered by the patient.        Should such determination be made, the system may additionally        be configured to indicate to the physician and the patient the        time frame of taking such action. For example, in this instance,        assuming once again that the proportion of non-terminal hair is        less than 20%, since the donor area is an A-type area, the        system may be configured to recommend that the patient may        undergo hair transplantation, for example, right away or that        they can wait (for example, up to 1 year), because the donor        area has sufficient hair and does not exhibit the symptoms of        hair loss. However, should the distribution of the various        classes of follicular units in the donor area be 22% of F1 s,        44% of F2 s, 33% of F3 s, and 1% of F4, indicating a B-type        area, the system may be configured to recommend that the patient        undergo a hair transplantation sooner (e.g., within a a two-year        time frame), to ensure that sufficient donor hair would still be        available to harvest and implant into the recipient areas in        light of the fact that such donor area already began to show the        symptoms of hair loss.

The examples above provide only samples of various configurations toprovide automatic determination of an action to take (or optionssuggested), and a time frame in which to take it, based upon the inputfrom an analysis of the proportions of classes of follicular units inthe donor areas, an analysis of the proportions of classes of follicularunits in the recipient areas and determination of whether theandrogenetic alopecia is present in a particular patient (for example,by determining proportions of the terminal or non-terminal hair). Itwill be appreciated that the results of steps 620, 630 and 650 can becombined to create an array of pre-selected actions to take, the actionsincluding, but not limited to initiating use of a topical hairenhancement product or treatment, hair growth stimulation product,undergoing hair transplantation, shaving one's head, or considering awig. In addition, associated recommended time-frames in which to takesuch action may also be provided. It will be appreciated that based onthe results of the steps 620, 630 and 650, only certain options will beallowed to be proposed as actions in step 670. For example, as discussedabove, if there is an insufficient density in the donor areas, forexample, hair transplantation may not be an option, even though theanalyzed proportions in the recipient region may be suggesting thataction to be an option. In other instances, hair transplantation may bean option, but the number of regions into which hair may be implantedmay be constrained by the availability of proportions of follicularunits available. In yet other situations, a determination of a densityin the potential recipient area of less than a predetermined number ofhair follicles or hair grafts per unit area (for example, 40 hairfollicles per 1 cm²), may dictate that a hair transplantationautomatically be considered as an option.

Consider a Caucasian male patient who comes to see his physicianexplaining that hair loss runs in his family, and that he wants to havea hair transplant. If the patient appears to have a full head of hair,with no noticeable reduction of density in any of the regions, eventhough the physician is aware that no hair transplant is needed at thisstage, the physician may still utilize this methodology to provide areference, a baseline to which future hair loss can be compared. Suchmethodology may be very useful, for example, to patients with the familyhistory of hair loss since the chances of this particular patientneeding hair transplantation at some point is relatively high. In thisparticular case, even no treatment is suggested during the initialpatient consultation, due to the patient's family history, it may besuggested that the patient return in 12 months to check if there hasbeen any change in his situation.

Should the same patient return in 6 months or other suggested time,after noticing that he can see significantly more scalp that usual inthe mirror, and has been picking up substantially more hair from theshower, the physician may once again utilize the methodology disclosed.It may be found, for example, that applying the methodology this timedetermines in step 620 that the proportion of the terminal hair is nowreduced, that the distribution of follicular units in the donor regions(step 650) is approximately 20% F1 s, 40% F2 s, 30% F3 s and 10% F4+s,and the distribution of follicular units in the recipient regions (step630) is approximately 31% F1 s and 63% F2 s, 5% F3, and 1% F4. Thoughthis example is somewhat extreme, it will be apparent that the patienthas experienced severe hair loss over a short period of time (thephysician has the results from the session 6 months ago to refer to).According to the methodology described herein, analysis of the resultsof steps 620, 630 and 650 this time will likely lead to recommendingsome type of testing to discover the reason for such accelerated hairloss and eventually an appropriate treatment, including, for example, ahair transplantation within a short period of time before the density ofthe donor area is reduced more. Of course, it will be appreciated thatthis may be one of several suggested actions, each with potentiallydifferent results. However, based on the information of proportions offollicular units available in the donor regions, the proportions offollicular units in the receiving regions, and the identifiedminiaturization and density, the physician will be able to manage theexpectation of results attainable based on the client's specific hairproportions and analysis.

Analysis of Hair Growth Phases to Determine the Timing and which Hair toHarvest and Implant

It is known that the hair in its life cycle goes through severalphysiological phases of hair growth. The anagen phase is the first phaseof the hair cycle during which new hair is growing and the hair follicleis elongating. The hair follicle actively produces the hair shaft (hairshaft production). This phase is the longest of the hair cycle typically3-10 years for the human scalp, with the duration of the anagen phaseresponsible for determining the length of the hair shaft. Due to thehigh mytotic rate of follicular matrix cells, the anagen phase is verysensitive to noxious insults. Approximately 75%-95% of hair follicles inthe scalp of a healthy person are normally in the anagen phase.

Catagen is the second phase of the hair cycle, a brief portion in thehair cycle when the hair growth stops and hair transitions to a restingperiod. This is a transitional phase which typically lasts 2-3 weeks andis characterized by apoptosis of the hair matrix cells and involution ofthe lower part of the follicle. During catagen phase, the hair bulbmigrates up from the hypodermis to the mid-dermis. Telogen, the finalphase, (resting phase) is the part of the hair cycle that follows thecatagen phase. During this phase hair shaft production is absent and thehair bulb is completely keratinized. The telogen phase, in the scalpfollicles, lasts about 3 to 4 months but it is considerably longer inother body regions such as the lower limbs. The hair shaft remainsanchored to the follicle during the telogen phase.

U.S. Pat. No. 6,985,611 is an example of state of knowledge, whichdescribes how to simulate the chronological evolution of a scalp overtime. The present disclosure teaches novel methods and device forplanning various procedures and treatments (such as hair transplantationprocedures and hair loss treatments), including determining the timingof such procedures and treatments and even how and which hairs to selectfor harvesting and subsequent implantation, based on the understandingof the evolution of the hair growth phases over time, as describedbelow.

A comparison of the anagen versus telogen hairs on the scalp isindicative of the health of the hair, with a healthy scalp havingapproximately 75% to 95% of the hair in the anagen phase. Hair in theanagen phase grows at approximately 0.35 mm per day (1 cm per month).Telogen hair does not grow. If less of a proportion of the hair is inthe anagen phase, this may be an indication of a condition calledtelogen effluvium which has multiple causes. These causes include, butare not limited to, the condition being due to: 1) a normal variant, 2)due to hormonal abnormalities (e.g. hypo/hyper thryroidism,hyperandrogenism, vitamin D or E deficiencies), 3) due to hyper-vitaminA, 4) due to iron deficiencies, 5) due to inflammatory disease, 6) dueto hyperprolactinism or other ailments. Understanding which hairs are inwhich hair growth cycle (and especially identifying hair in the anagengrowth phase) is useful in planning hair transplantation, according tothe present disclosure. By selecting particular follicles to harvest andimplant based on their hair growth phase, or by choosing a timing of theprocedure or treatment based, for example, on the overall condition ofthe hair growth phases of the hair and the distribution over therelevant surface of the hairs in different hair growth phases, a moresuccessful outcome may be realized, and a cosmetic impact after hairtransplantation to be realized sooner.

In one aspect of the disclosure, as illustrated in FIG. 7, prior toundergoing a hair transplantation procedure, the proportion of hair inthe anagen growth phase is determined. This determination may be madefirst determining how much hair in the region of interest is in each ofthe hair growth phases, as shown in step 710. This step may beaccomplished by various methodologies, including those described in theU.S. Pat. No. 6,985,611 incorporated herein by reference. For example,in some embodiments the step 710 may comprise the following:

1) As a preliminary step, identifying a region of interest, such as anarea on the body surface, comprising hair. Such area may have a diameterof 1 cm, for example.

2) As another preliminary step, cutting a population of hair in thisarea or region of interest to a predetermined length, approximately 0.5mm-1.0 mm in length.

3) Acquiring a first image at a first moment in time, for example, bymeans of an imaging system, detecting hair and determining a firstlength of each hair of the population of hair within the area that wascut. The first length is determined, for example, from the point atwhich it emerges from the body surface to its tip (proximal to the bodysurface).

4) At a second moment in time, for example one to three days from thefirst time, the same area is re-imaged, providing a second image, hairdetected and a second or new length determined for each hair in the area(the length determined in the same manner as previously).

5) Automatically comparing a first length of a hair at a first moment intime to a second length of the hair at a second moment in time andrepeating the comparison for a plurality of hairs in a region ofinterest. Such comparison may be done, for example, by means of analgorithm executed by a processor. Based on the comparison of the secondlength to the first length, classifying the phase of hair growth forhair in the area (in some implementation it could be for each hair inthe area, in some only for a certain representative number of hairs inthe area).

In one embodiment, classification of hair to be in an anagen growthphase comprises hair that has grown more than 0.25-0.45 mm per day, forexample 0.33 mm per day, during the first and second time. Hair that hasnot substantially grown comprises hair in a telogen growth phase.Therefore, in one example, if the time between the first and secondimages being acquired is 3 days, anagen hair would be identified to bethe hair that had grown about 1 mm over the 3 day period of time. Suchclassification may be done automatically, for example, by a processor.

Having determined which hairs of the population of hair in the area arein the anagen growth phase, in one aspect of the current disclosure, adetermination is made of the proportion or percentage of hair within thearea that is in the anagen phase, step 720. If it is determined (step730) that the proportion or percentage of hair within the area that isin the anagen phase is 75% or greater, such a patient is a preferredcandidate for hair transplantation, the hair transplantation procedurecan proceed, and a date for the procedure may be scheduled, for example,to be within a year, or within 3 months, or any other appropriate timeframe. In some embodiments an indication of such may be relayed to theoperator (step 740), on a display screen, for example. The determinationto proceed with the procedure as well as the proposed timing of theprocedure may be automatically proposed by the system (based, forexample, on the pre-programmed information), or it may be selected bythe user (physician) from the several options available through the userinterface, or it may be chosen directly by the physician. Hair that isharvested during its anagen phase for subsequent implantation in a hairtransplantation will have a higher chance of growingpost-transplantation, and therefore, aid in a successful hairtransplantation and achieving desired aesthetic outcome.

If, however, a patient undergoes the above analysis, and it isdetermined at step 730 that a proportion of less than 75% of the hairpopulation in the area is in the anaphase growth phase, a determinationwould be made that such a patient should not proceed with a hairtransplantation at this time, and such determination may once again berelayed to the operator, on a display screen. With this determination,there are several options that may be considered. One such option is forthe patient to be advised be undergo the anagen/telogen/catagen growthphase analysis again after an appropriate time has passed, for examplewithin a time-frame or period of 3 months to 6 months (step 750). Asindicated earlier, hair which is in a telogen growth phase takesapproximately 3 months to pass through this phase, and enter the anagengrowth phase again. After the 3-6 months period has passed, the patientwould under the analysis again, in the hope of a determination beingmade of a proportion of 75% or greater of the hair in the area in theanagen growth phase, and hence being able to proceed with a hairtransplantation process. In another option, the determination may dependupon the actual proportion or percentage of hair in the area that is inthe anagen growth phase. For example, a determination may be made if theproportion or percentage of hair in the area that is in the anagengrowth phase in the range of 40-75% (step 760), should the result bepositive, a determination may be made that during the next 3-6 months,prior to the next analysis being carried out, the patient should apply amedication, a hair growth stimulant, such as Minoxidil or Finasteride(770), and then determine the proportion again in 3-6 months. In theevent that the result is negative, meaning that the proportion orpercentage of hair in the area that is in the anagen growth phase isless than 40%, it may indicate that the patient has some potentialhealth issues and a determination may be made that additional tests arerequired (780) to find out why the percentage is so low and discover thecause of the issue. For such a patient, hair transplantation or topicalmedications may not be a sufficient option. For such a patient, theinformation attained may dictate that other tests be required in orderto find out why the proportion of hair in the anagen growth phase is solow, and potentially identify a medical condition the patient may have.

In this manner, based on the proportion or percentage of hair in thearea that is in the anagen growth phase, a determination may be as tothe best time for a patient to have a procedure, the best time definedas the time which will most likely result in a successful procedure.Based on the proportion of hair the anagen growth phase, a determinationmay also be made to exclude a patient from being a candidate for a hairtransplantation.

In a further aspect of the current disclosure, a determination of whichhair are in the anagen hair growth phase may also be utilized during theactual hair transplantation procedure. During the hair transplantationprocedure, the image processing unit may be configured (for example,with algorithms) such that once anagen hair have been identified (aproportion that will be greater than 75%, but less than 100%), thesystem can be configured such that only hair determined to be in theanagen growth phase is selected to be harvested for transplantation.However, since hair is harvested typically as a follicular unit andseveral follicles within such unit may be in different hair growthphases, some alternative approaches may be following. For example, inone embodiment, if it is determined that a proportion of greater than75% of the hair follicles is in the anagen growth phase, there is a highprobability that as follicular units are harvested, the majority of thepopulation of follicles harvested will end up being in the anagen growthphase. Alternatively, for a multi-follicle follicular unit, should onlyone of the hair follicles within the follicular unit not be in theanagen growth phase, the system may be configured to harvest thatparticular follicular unit. Should on the other hand, more than half ofthe hair follicles within the follicular unit not be in the anagengrowth phase, the system may be configured not to harvest thatparticular follicular unit. In other embodiments, the decision on whichfollicular units to harvest may depend upon the type of class offollicular unit. For example, if a F2 comprises one hair follicle thatis not in the anagen growth phase, it may be determined that suchfollicular unit will not be harvested. On the other hand, if a F3comprises one hair follicle that is not in the anagen growth phase butthe other two follicles are, it may be determined that the entirefollicular unit be harvested. However for a F3 comprising two hairfollicles that are not in anagen growth phase, it may be determined notto harvest any part of that follicular unit at all. These variousscenarios may be programmed such that the system may automaticallydetermine which hair to harvest, or the user may make an appropriateselection using user interface.

To aid in easily identifying and indicating to the physician (or otheruser) those hairs that are in anagen state, a further aspect of thedisclosure provides a method and corresponding device by which theproportion of hair that is determined to be in the anagen growth phasemay be assigned a representation and an image of the predefined region,for example, populated with the assigned representation (similar to thatdescribed with references to FIG. 1 above). Such a method for usinganalysis of hair growth phase to plan hair transplantation, maycomprise: identifying one or more hair follicles within a predefinedregion on the body surface; determining a type of hair growth phase forthe one or more hair follicles; determining a proportion of hair in theanagen hair growth phase; assigning a representation to and populatingthe predefined region with only those representations corresponding tohair in an anagen hair growth phase; and planning a hair transplantprocedure based at least in part on the determined proportion of theanagen hair and/or on a distribution of the populated representation.Planning may comprise determining when to undergo a hair transplantationprocedure and/or which hair to harvest during the transplantation. Therepresentations may also aid in providing a metric, providing not onlyan indication of the proportion of hair in the anagen hair growth phase,but also their distribution throughout the predefined area (or area ofinterest). Such metrics may be utilized for example, to provide anindication of the size of a hair harvesting session, which will bebased, for example, on the number of hairs that can be harvested withoutcompromising the remaining density of hair according to the determineddistribution of hair in the anagen phase, and further based on that thenumber of sessions that may be required and how far apart such sessionswill be scheduled based on the available hair in the anagen phase.

In some embodiments, only a sample area of the body scalp will typicallybe analyzed in the manner described above. In these embodiments,assuming that from the sample it is determined that the proportion ofhair in the anagen growth phase is greater than 80%, the system may beconfigured by means of algorithms in the image processing unit tospecify that hairs of less than 40 microns in caliber (vellus hair) andhair that is not greater than, for example, 0.8 mm in length does notqualify to be harvested. Such approach would allow selecting only hairthat hopefully meets the criteria of being more than 40 microns incaliber and great than 0.8 mm in length, hence more likely to be in theanagen growth phase, and excluding hairs that do not qualify. In thismanner, the sample area can be utilized to predict the proportion ofhair in the anagen growth phase throughout the rest of the relevant bodysurface.

In a further aspect of the disclosure, there may be circumstances inwhich even though it may be preferable that hair be harvested when 75%of the hair population in the predefined area is in the anagen hairgrowth phase, transplantation of at least some of the anagen hair stillbe performed. Such circumstances may include, though are not limited to,situations in which it is determined that the patient's hair loss isprogressing at a significant rate (for example, based on performing themethodologies described earlier in reference to determining terminal andnon-terminal hair). For example, the methodology discussed in referenceto FIG. 7 may be combined with any of the methodologies discussed inreference to other embodiments of the present disclosure. Perhaps,identifying proportions of the terminal and non-terminal hair follicles(and/or analyzing the rapid negative change of such proportions over ashort period of time) may indicate that the patient may rapidly lose asignificant amount of hair, including many healthy hairs that arecurrently available in anagen state. Under these circumstances, thephysician may consider it in the patient's best interest to select hairin the anagen hair growth phase from the determined proportion, eventhough it is less than 75%. Therefore due to limitations imposed such astime constraints, there may be situations in which the 75% be modifiedto a lower value.

In accordance with various embodiments of the disclosure, a system forplanning a procedure for transplantation of follicular units in a bodysurface (e.g., a scalp) of a patient may comprise a user interface,processor (e.g., software-controlled), a monitor, and at least one inputdevice. These components are common to virtually all modern computersystems, whether a stand-alone (e.g., “personal”) computer system, or ina system employing a centralized server with multiple remoteterminal(s). It will be appreciated that embodiments of the planningsystem are preferably (if not exclusively from a practical point ofview) software implemented, and may be run on any computer system havingthe basic components (processor, monitor, input device), so long as suchcomputer system is equipped with sufficient available memory and anappropriate graphic generation and display capability. The computingsystem may include one or more processing units, one or morenon-transitory storage media (which may take the form of, but is notlimited to, a magnetic storage medium; optical storage medium;magneto-optical storage medium; read only memory; random access memory;erasable programmable memory; flash memory; and so on), and/or one ormore input and/or output components for transmitting output to and/orreceiving input from one or more other components (such as one or moredisplays, touch screens, keyboards, mice, track pads, track balls,styluses, pens, printers, speakers, cameras, video cameras, and so on).The processing unit may comprise one or more modules to executeinstructions stored in the storage medium in order to perform one ormore computing device functions, such as one or more treatment planningmethods. The system or the processing unit may additionally include animage repository, the image repository comprising templates, images ofone or more patients and/or images of portions of templates or patients.The system can be configured to implement all the methodologies,processes and techniques described herein. In another embodiment of thedisclosure, the modules may be executed to run on handheld devices, forexample mobile phones, smart phone, or other such devices which are alsoable to capture images of the body surface, taking the form of anapplication to downloaded onto the phone by the user.

Although it may be suggested that the computing system includeparticular components arranged in a particular configuration, it isunderstood that this is for the purposes of example. In variousimplementations, the computing system may include any number ofcomputing system components (such as one or more busses, displays,networking components, dedicated image processors, co-processors,memories, hard drives, ports, graphics adapters, and so on) arranged indifferent configurations without departing from the scope of the presentdisclosure. For example, in one or more implementations the computingsystem may include multiple cameras and/or video cameras arranged tocapture images and/or video of the same scene. By way of anotherexample, in various implementations the computing system may include oneor more interfaces for controlling machinery such as automated and/orcomputer-assisted surgical machinery.

It will also be appreciated that embodiments of the disclosure may beimplemented over the internet, e.g., with a user of such systememploying his or her home computer as at least a part of the userinterface (monitor and input device) that interacts with a remote serveror computer. In such an internet-based planning system, the softwarethat implements and controls the user interface may reside in whole orpart on the user's computer or on the remote server/computer, preferablytransparent to the user. In one such embodiment, the remote serverdownloads one or more software modules to the user's computer fortemporary or permanent use.

It is to be understood that other embodiments than those described abovemay be utilized and structural or logical changes may be made withoutdeparting from the scope of the present disclosure. The DetailedDescription, therefore, is not to be taken in a limiting sense, and thescope of the present disclosure is defined by the appended claims. Itwill also be apparent that although the methodology described above asdiscrete steps, one or more steps may be combined or even deleted,without departing from the intended functionality of the embodiments ofthe disclosure. It will also be apparent that the methods describedabove may be performed manually, or they may be partially orsubstantially automated, including performed using robotic systems.

It will also be appreciated that the foregoing illustrated and describedembodiments of the disclosure are susceptible to various modificationsand alternative forms, and it should be understood that the applicationsas generally disclosed herein, as well as the specific embodimentsdescribed herein, are not limited to the particular forms or methodsdisclosed, and that many other embodiments are possible within thespirit and the scope of the present disclosures. Moreover, althoughindividual features of one embodiment may be discussed herein or shownin the drawings of the one embodiment and not in other embodiments, itshould be apparent that individual features of one embodiment may becombined with one or more features of another embodiment or featuresfrom a plurality of embodiments. By way of non-limiting example, it willbe appreciated by those skilled in the art that particular features orcharacteristics described in reference to one figure or embodiment maybe combined as suitable with features or characteristics described inanother figure or embodiment. Applicant regards the subject matter ofthe disclosure to include all combinations and sub-combinations of thevarious steps, elements, features, functions, and/or propertiesdisclosed herein.

What is claimed is:
 1. A method for creating a realistic simulation ofhair loss or hair gain, the method comprising: displaying, on a displaydevice, individual hair follicles or follicular units in a region ofinterest in an image; simulating or allowing a user to simulate anappearance of the region of interest with a change in density of hair;and automatically adjusting the simulated appearance of the changeddensity to reflect an achievable density that takes into account one ormore calculated constraints; and displaying, on the display of thedisplay device, the adjusted simulated appearance of the region ofinterest; wherein the calculated constraints comprise one or more of thefollowing: an available number of hair grafts in a donor area, anassociated classification of available donor hair grafts, a size of atool, or how close hair may be implanted to existing or previouslyimplanted hair.
 2. A system for creating a realistic simulation of hairloss or hair gain, the method comprising: a display configured todisplay an image of a region of interest comprising individual hairfollicles or follicular units; a user interface configured to receiveinput from a user, including input comprising a simulated change indensity of hair in the region of interest; at least one non-transitorystorage medium storing instructions, and one or more modules forexecuting operations on image data, the one or more modules comprisinginstructions for: automatically adjusting and displaying the simulatedappearance of the changed density to reflect an achievable density thattakes into account one or more calculated constraints; wherein the userinterface is displayed on the display simultaneously with the individualhair follicles or follicular units; wherein the user interface comprisesan indication of the density of the hair follicles or follicular units;and wherein the user interface comprises a sliding bar to change thedensity of hair.
 3. The system of claim 2, wherein automaticallyadjusting and displaying the simulated appearance of the changed densityto reflect an achievable density that takes into account one or morecalculated constraints comprises removing individual hair follicles orfollicular units from the display of the simulated appearance when theinput of the simulated change in density of hair in the region ofinterest is a reduction in the density of hair in the region oninterest.
 4. The system of claim 2, wherein automatically adjusting anddisplaying the simulated appearance of the changed density to reflect anachievable density that takes into account one or more calculatedconstraints comprises adding individual hair follicles or follicularunits to the display of the simulated appearance when the input of thesimulated change in density of hair in the region of interest is anincrease in the density of hair in the region on interest.
 5. The systemof claim 4, wherein the user interface comprises an input element thatallows a user to activate a highlight feature in which the individualhair follicles or follicular units that were added to the simulatedappearance in response to the input are highlighted relative toindividual hair follicles or follicular units that were displayed beforethe input.
 6. The system of claim 2, wherein the user interfacecomprises input elements that correspond to different classes offollicular units, wherein the classes of follicular units correspond tothe number of individual hair follicles in a follicular unit, andwherein the input elements include a selection mechanism, which whenactivated, displays follicular units in the corresponding class in ahighlighted manner relative to follicular units of classes that areunselected.
 7. The system of claim 2, wherein the user interfacecomprises an input element that corresponds vellus hair, wherein theinput element includes a selection mechanism, which when activated,displays follicular units that are vellus hair in a highlighted mannerrelative to follicular units of classes that are unselected.
 8. A systemfor creating a realistic simulation of hair loss or hair gain, themethod comprising: a display configured to display an image of a regionof interest comprising follicular units; a user interface configured toreceive input from a user, the user interface comprising input elementsthat correspond to different classes of follicular units, wherein theclasses of follicular units correspond to the number of individual hairfollicles in a follicular unit, and wherein the input elements include aselection mechanism, which when activated, causes follicular units inthe corresponding class to be displayed in a highlighted manner relativeto follicular units of classes that are unselected; at least onenon-transitory storage medium storing instructions, and one or moremodules for executing operations on image data, the one or more modulescomprising instructions for: displaying follicular units in classes thathave been selected through the user interface in a highlighted mannerrelative to follicular units of classes that are unselected.
 9. Thesystem of claim 8, wherein the user interface is displayed on thedisplay simultaneously with the individual hair follicles or follicularunits.
 10. A system for creating a realistic simulation of hair loss orhair gain, the method comprising: a display configured to display animage of a region of interest comprising individual hair follicles orfollicular units; a user interface configured to receive input from auser, including input comprising a simulated change in density of hairin the region of interest; at least one non-transitory storage mediumstoring instructions, and one or more modules for executing operationson image data, the one or more modules comprising instructions for:automatically adjusting and displaying the simulated appearance of thechanged density to reflect an achievable density that takes into accountone or more calculated constraints; wherein the user interface isdisplayed on the display simultaneously with the individual hairfollicles or follicular units; and wherein automatically adjusting anddisplaying the simulated appearance of the changed density to reflect anachievable density that takes into account one or more calculatedconstraints comprises removing individual hair follicles or follicularunits from the display of the simulated appearance when the input of thesimulated change in density of hair in the region of interest is areduction in the density of hair in the region on interest.
 11. A systemfor creating a realistic simulation of hair loss or hair gain, themethod comprising: a display configured to display an image of a regionof interest comprising individual hair follicles or follicular units; auser interface configured to receive input from a user, including inputcomprising a simulated change in density of hair in the region ofinterest; at least one non-transitory storage medium storinginstructions, and one or more modules for executing operations on imagedata, the one or more modules comprising instructions for: automaticallyadjusting and displaying the simulated appearance of the changed densityto reflect an achievable density that takes into account one or morecalculated constraints; wherein the user interface is displayed on thedisplay simultaneously with the individual hair follicles or follicularunits; and wherein automatically adjusting and displaying the simulatedappearance of the changed density to reflect an achievable density thattakes into account one or more calculated constraints comprises addingindividual hair follicles or follicular units to the display of thesimulated appearance when the input of the simulated change in densityof hair in the region of interest is an increase in the density of hairin the region on interest.
 12. A system for creating a realisticsimulation of hair loss or hair gain, the method comprising: a displayconfigured to display an image of a region of interest comprisingindividual hair follicles or follicular units; a user interfaceconfigured to receive input from a user, including input comprising asimulated change in density of hair in the region of interest; at leastone non-transitory storage medium storing instructions, and one or moremodules for executing operations on image data, the one or more modulescomprising instructions for: automatically adjusting and displaying thesimulated appearance of the changed density to reflect an achievabledensity that takes into account one or more calculated constraints; andwherein the user interface comprises input elements that correspond todifferent classes of follicular units, wherein the classes of follicularunits correspond to the number of individual hair follicles in afollicular unit, and wherein the input elements include a selectionmechanism, which when activated, displays follicular units in thecorresponding class in a highlighted manner relative to follicular unitsof classes that are unselected.
 13. A system for creating a realisticsimulation of hair loss or hair gain, the method comprising: a displayconfigured to display an image of a region of interest comprisingindividual hair follicles or follicular units; a user interfaceconfigured to receive input from a user, including input comprising asimulated change in density of hair in the region of interest; at leastone non-transitory storage medium storing instructions, and one or moremodules for executing operations on image data, the one or more modulescomprising instructions for: automatically adjusting and displaying thesimulated appearance of the changed density to reflect an achievabledensity that takes into account one or more calculated constraints; andwherein the user interface comprises an input element that correspondsvellus hair, wherein the input element includes a selection mechanism,which when activated, displays follicular units that are vellus hair ina highlighted manner relative to follicular units of classes that areunselected.